CPhI Annual Report

CPhI World­wide, the world’s largest phar­ma event, releas­es its annu­al report analy­sis of opi­oid con­tract ser­vices and con­tin­u­ous man­u­fac­tur­ing. Ahead of the event’s open­ing next week, the find­ings high­light major treats and oppor­tu­ni­ties for CDMOs and phar­ma com­pa­nies over the next 1–5 years.
Emil W. Ciur­czak, of Dora­maxx Con­sult­ing, and Fiona Bar­ry, edi­tor at Pharm­Source, a Glob­al­Da­ta prod­uct, respec­tive­ly analysed ‘the effects of con­tin­u­ous man­u­fac­tur­ing’ and ‘con­tract man­u­fac­tur­ing in light of recent DEA quo­ta changes for con­trolled substances’.
Over the next five years, Emil Ciur­czak pre­dicts expo­nen­tial growth of con­tin­u­ous man­u­fac­tur­ing dri­ven by com­pet­i­tive and finan­cial pres­sures, bet­ter equip­ment and a larg­er pool of trained sci­en­tists.  He bold­ly pre­dicts that all gener­ic man­u­fac­tur­ers and CMOs will need to con­vert to con­tin­u­ous man­u­fac­tur­ing facil­i­ties in the next 10-years.
“The com­pa­nies who have begun using CM have enjoyed (over­all) suc­cess, mak­ing prod­ucts faster and with vir­tu­al­ly no rejects. The move­ment from devel­op­ment to full-scale pro­duc­tion, skip­ping the scale-up step (as much as six months) brings the prod­ucts to mar­ket faster. The ques­tion is no longer, “Will Con­tin­u­ous Man­u­fac­tur­ing work?”, but “When will every­one be doing it?”, added Ciurczak.
He sug­gests that many phar­ma­ceu­ti­cal com­pa­nies may not yet feel the need to con­vert to con­tin­u­ous man­u­fac­tur­ing, as there is less finan­cial incen­tive to stream­line the man­u­fac­tur­ing process for inno­v­a­tive med­i­cines, which can yield thou­sands of dol­lars of prof­its. How­ev­er, he explains that indus­try-wide changes are putting pro­duc­tion costs under new scruti­ny. Com­pe­ti­tion between coun­tries, the impo­si­tion of pric­ing restric­tions and the con­stant cost of R&D means that sim­ply rais­ing prices to con­sumers may no longer be a viable option so ulti­mate­ly, he fore­casts that big phar­ma that declines to invest will be left behind – and this change will take place with­in the next 5–10 years.
Fiona Bar­ry iden­ti­fied oppor­tu­ni­ties and threats cre­at­ed by recent changes in US reg­u­la­tions. In par­tic­u­lar, she pre­dict­ed many CMOs will be hit hard by the pro­posed pro­duc­tion cut of opi­oid com­pounds by the DEA to com­bat the opi­oid addic­tion cri­sis. Con­verse­ly, she also pre­dict­ed that the devel­op­ment of non-opi­oid painkillers could be a pos­si­ble replace­ment rev­enue stream and will become a prof­itable oppor­tu­ni­ty for CMOs and drug com­pa­nies in the near future.
“Out of the 30 CMOs involved in com­mer­cial drug man­u­fac­ture using con­trolled sub­stances, 18 (60%) pro­duce opi­oids. While con­trac­tors involved in con­trolled sub­stance pro­duc­tion con­sti­tute a minor­i­ty of US CMO facil­i­ties, it is clear that they will be hit par­tic­u­lar­ly hard by the reduced vol­umes of opi­oid man­u­fac­tur­ing. The ever-grow­ing num­ber of opi­oid lawsuits—such as the US state law­suits against Pur­due Pharma—is like­ly to deter phar­ma com­pa­nies from pro­duc­ing and out­sourc­ing these prod­ucts in the future.
In addi­tion to these oppor­tu­ni­ties, Bar­ry went on to pre­dict that there may also be many new approvals for cannabis-derived drugs in the pipeline. She point­ed to shift­ing reg­u­la­to­ry atti­tudes – fol­low­ing the first FDA approval of a plant-derived cannabi­noid drug, Epid­i­olex – as well as the recent DEA quo­ta changes, which will increase max­i­mum mar­i­jua­na vol­umes by 250% in 2019 as evi­dence of these emerg­ing trends.
CPhI Brand Direc­tor Europe, Orhan Caglayan added: “These find­ings are par­tic­u­lar­ly rel­e­vant to many of the CDMO exhibitors at ICSE who are already explor­ing and invest­ed in con­tin­u­ous man­u­fac­tur­ing approach­es. Our experts sug­gest the indus­try may now be under­go­ing a fun­da­men­tal long-term shift in man­u­fac­tur­ing and many of the ses­sions at CPhI World­wide will explore these impli­ca­tions. Sim­i­lar­ly, there are clear­ly both oppor­tu­ni­ties and chal­lenges ahead in the short and long term in rela­tion to opi­oid and alter­na­tives man­u­fac­tured for the US mar­ket. This is an evolv­ing space and I would encour­age both brand­ed phar­ma and CDMOs to study how they adjust their busi­ness, with CBD com­pounds wide­ly seen to rep­re­sent a quick­ly grow­ing sector.